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With over 1.4 billion adults worldwide categorized as overweight or obese and an increase in obesity-related health conditions, a need for effective treatment and management modalities is crucial. Intragastric balloons serve as a minimally invasive tool to combat the obesity pandemic. There are multiple intragastric balloons approved for the United States and European markets. Indications in the USA include a BMI of 30 to 35 kg/m2 but a BMI of 27 to 35 kg/m2 in Europe. This activity reviews the indications, contraindications, and pathophysiology of intragastric balloons and highlights the role of the interprofessional team in evaluating and treating this condition. Objectives: Assess the history and development of the intragastric balloon. Identify the pathophysiology of intragastric balloon therapy. Assess the risks and benefits of intragastric balloon therapy. Access free multiple choice questions on this topic.

Since the beginning of the 1980s, the worldwide prevalence of obesity has doubled. An estimated 1 in 3 adults is categorized as overweight or obese, equating to greater than 1.4 billion adults. Given the epidemic rates of obesity and the subsequent rise in the prevalence of obesity-related health conditions and comorbidities, there is a global need for effective and safe treatment of this disease. Comorbidities include hypertension, hyperlipidemia, cardiovascular disease, diabetes mellitus, orthopedic conditions, gastroesophageal reflux disease, metabolic dysfunction, psychiatric disorders, obstructive sleep apnea, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, and cancers.[1][2] While bariatric surgery is considered the most effective treatment modality for morbid obesity, there are restrictions for a patient to be a candidate for surgical intervention. Bariatric surgeries, which range from Roux-en-Y gastric bypass, duodenal switch, laparoscopic sleeve gastrectomy, to name a few, require a body mass index (BMI) greater than 35 kg/m2 with associated comorbidities or meeting the BMI criteria for severe obesity with a BMI greater than 40 kg/m2.[3] With the parameters mentioned above to meet preoperative criteria, this leaves an intermediate group of patients who are not candidates for surgery but have also failed or not responded well to medical therapies. These patients are also looking for a safe and effective weight-loss therapy that is minimally invasive, like the intragastric balloon. Current treatment modalities for obese patients include lifestyle modifications, pharmacotherapy, bariatric surgery, and endoscopic applications, of which the intragastric balloon is the most widely used.

While bariatric surgery is considered the most effective treatment modality for morbid obesity, there are restrictions for a patient to be a candidate for surgical intervention. Bariatric surgeries, which range from Roux-en-Y gastric bypass, duodenal switch, laparoscopic sleeve gastrectomy, to name a few, require a body mass index (BMI) greater than 35 kg/m2 with associated comorbidities or meeting the BMI criteria for severe obesity with a BMI greater than 40 kg/m2.[3] With the parameters mentioned above to meet preoperative criteria, this leaves an intermediate group of patients who are not candidates for surgery but have also failed or not responded well to medical therapies. These patients are also looking for a safe and effective weight-loss therapy that is minimally invasive, like the intragastric balloon. Current treatment modalities for obese patients include lifestyle modifications, pharmacotherapy, bariatric surgery, and endoscopic applications, of which the intragastric balloon is the most widely used. Intragastric balloon therapies are a minimally invasive and temporary methodology to induce weight loss in obese patients. The soft saline or an air-filled balloon is placed into the stomach, typically in an endoscopic fashion. The balloon is a restrictive mechanism and promotes the feeling of satiation as it is a space-occupying device. The average gastric capacity is approximately 1200 mL, but an obese patient can stretch this volume threefold. A balloon volume of 400 mL or higher is enough to induce the feeling of satiation.[4] A proposed mechanism of action is the delayed gastric emptying process, which can serve as a contributing weight-loss factor. Importantly, as with all bariatric procedures, a patient must comply with lifestyle modifications to achieve and maintain meaningful weight loss before and after any intervention. History

Intragastric balloon therapies are a minimally invasive and temporary methodology to induce weight loss in obese patients. The soft saline or an air-filled balloon is placed into the stomach, typically in an endoscopic fashion. The balloon is a restrictive mechanism and promotes the feeling of satiation as it is a space-occupying device. The average gastric capacity is approximately 1200 mL, but an obese patient can stretch this volume threefold. A balloon volume of 400 mL or higher is enough to induce the feeling of satiation.[4] A proposed mechanism of action is the delayed gastric emptying process, which can serve as a contributing weight-loss factor. Importantly, as with all bariatric procedures, a patient must comply with lifestyle modifications to achieve and maintain meaningful weight loss before and after any intervention. History The study of intragastric restriction dates back to 1939, with the investigation of gastric bezoars by Michael DeBakey. His analysis concluded that approximately 30% of patients with gastric bezoars and concretions had experienced weight loss.[5] Patients analyzed suffered from gastrointestinal symptoms, most commonly nausea and vomiting, and did not necessarily lose weight. The first intragastric balloon introduced in 1985 was created by husband-and-wife gastroenterologists Lloyd Garren and Mary Garren. This balloon was introduced in the United States and was called the Garren-Edwards Gastric Bubble (GEGB). The GEGB was a cylindrical, “tin can” shape with a central, hollow channel for insertion and retrieval in an endoscopic fashion. This balloon was filled with approximately 200 mL of room air and placed in the stomach for 4 months. This intragastric balloon received approval from the Food and Drug Administration (FDA) but was withdrawn from the market in 1992 due to severe side effects. Complications included gastric ulcers, Mallory-Weiss tears, small bowel obstructions, and gastric erosion. There was also insufficient efficacy in weight loss with patients using these devices.

The study of intragastric restriction dates back to 1939, with the investigation of gastric bezoars by Michael DeBakey. His analysis concluded that approximately 30% of patients with gastric bezoars and concretions had experienced weight loss.[5] Patients analyzed suffered from gastrointestinal symptoms, most commonly nausea and vomiting, and did not necessarily lose weight. The first intragastric balloon introduced in 1985 was created by husband-and-wife gastroenterologists Lloyd Garren and Mary Garren. This balloon was introduced in the United States and was called the Garren-Edwards Gastric Bubble (GEGB). The GEGB was a cylindrical, “tin can” shape with a central, hollow channel for insertion and retrieval in an endoscopic fashion. This balloon was filled with approximately 200 mL of room air and placed in the stomach for 4 months. This intragastric balloon received approval from the Food and Drug Administration (FDA) but was withdrawn from the market in 1992 due to severe side effects. Complications included gastric ulcers, Mallory-Weiss tears, small bowel obstructions, and gastric erosion. There was also insufficient efficacy in weight loss with patients using these devices. The failures of the GEGB promoted the 1987 conference titled Obesity and the Gastric Balloon: A Comprehensive Workshop. This obesity congress included 75 international experts from gastroenterology, surgery, nutrition, behavioral medicine, and obesity specialists.[6] This meeting aimed to develop a consensus on the technology of intragastric balloons and treatment options. The ideal balloon characteristics should include high efficacy, radiopaque markers, adjustability to a variety of sizes between 400 and 500 mL, low ulcer and obstructive potential, absence of edges or sharp ridges, the composition of materials that last for long periods, made to maximize both weight-loss and limit the amount of food intake. According to this conference, the usage of intragastric balloon therapy was for patients whose BMI did not qualify for operative bariatric procedures but desired to improve an obesity-associated condition or to lose excess weight. The intragastric balloons could also be utilized for patients with an extremely high BMI who are either unfit for bariatric surgery or to reduce body weight before bariatric surgery.[6]

The failures of the GEGB promoted the 1987 conference titled Obesity and the Gastric Balloon: A Comprehensive Workshop. This obesity congress included 75 international experts from gastroenterology, surgery, nutrition, behavioral medicine, and obesity specialists.[6] This meeting aimed to develop a consensus on the technology of intragastric balloons and treatment options. The ideal balloon characteristics should include high efficacy, radiopaque markers, adjustability to a variety of sizes between 400 and 500 mL, low ulcer and obstructive potential, absence of edges or sharp ridges, the composition of materials that last for long periods, made to maximize both weight-loss and limit the amount of food intake. According to this conference, the usage of intragastric balloon therapy was for patients whose BMI did not qualify for operative bariatric procedures but desired to improve an obesity-associated condition or to lose excess weight. The intragastric balloons could also be utilized for patients with an extremely high BMI who are either unfit for bariatric surgery or to reduce body weight before bariatric surgery.[6] Using the characteristics and conclusions from the Obesity and the Gastric Balloon conference, a balloon was developed in 1991 by the BioEnterics Corporation. This balloon contained a saline and methylene blue mixture and would remain in the stomach for 6 months. Initially, this balloon was used outside North America in Asia, South America, Europe, and the Middle East. The balloon, called Orbera, eventually received FDA approval in the United States in 2015.[4] Since 2015, different intragastric balloon systems have been introduced to the United States and European markets. The usage of these balloons ranges from primary weight loss, a bridging therapy for bariatric surgery, and a weight-loss solution for high-risk patients. Attracting factors to intragastric balloons include the little to noninvasive nature, limited to a specific time frame, and reversible. The intragastric balloon also preserves the anatomy of the stomach. It is important to note that weight loss is not comparable to that expected from a surgical procedure. Intragastric balloons can be used as a weight-loss tool but are ineffective for weight maintenance. The advantages and disadvantages must be analyzed individually when making a medical therapy decision with a patient.[7]

Given the non-invasive or minimally invasive intragastric balloon procedure, it has gained popularity as a weight-loss procedure. However, adverse events do occur. Patients were analyzed for adverse events in a retrospective analysis that included over 1000 procedures between 2016 and 2017. Approximately 7.2% of these patients had required treatment for dehydration, 2% required readmission, 1.1% needed re-operation, and 6.2% necessitated intervention within the first 30 days. A study of over 145,000 patients found that intragastric balloon therapy had a higher adverse event rate than laparoscopic bariatric surgery. Specifically, this was due to a significantly higher non-operative re-intervention rate in the intragastric balloon group versus the laparoscopic bariatric surgery group.[25] Gastrointestinal symptoms, including nausea, abdominal pain, vomiting, dyspepsia, constipation, acid reflux, and burping, are typical symptoms of intragastric balloon therapy. Gastric accommodation to the intragastric balloon is why gastrointestinal symptoms occur. Approximately 91% of patients have some form of the symptoms.[22] Patients have been prescribed medications to aid in controlling these symptoms. A proton pump inhibitor is started before balloon insertion. An anti-emetic medication like ondansetron or aprepitant is often prescribed for as-needed use. During the first week of intragastric balloon therapy, an anticholinergic medication such as scopolamine can be used. Prospective studies have demonstrated that a serotonin receptor antagonist may be effective when combined with midazolam. If a patient experiences persistent symptomatology, the balloon may be removed out of necessity.[26] Approximately 4 to 7% of patients have significant gastrointestinal symptoms after the first 7 days of therapy. Less than 3% of these patients require an endoscopic re-intervention or early balloon removal. The safety profile of intragastric balloons is of importance. Serious adverse events from the balloon, including gastric perforation, balloon migration, and mortality, are rare. A meta-analysis of intragastric balloon risks determined that gastric perforation rate is approximately 0.1%, balloon migration 1.4%, and mortality 0.08%.[27]

Gastrointestinal symptoms, including nausea, abdominal pain, vomiting, dyspepsia, constipation, acid reflux, and burping, are typical symptoms of intragastric balloon therapy. Gastric accommodation to the intragastric balloon is why gastrointestinal symptoms occur. Approximately 91% of patients have some form of the symptoms.[22] Patients have been prescribed medications to aid in controlling these symptoms. A proton pump inhibitor is started before balloon insertion. An anti-emetic medication like ondansetron or aprepitant is often prescribed for as-needed use. During the first week of intragastric balloon therapy, an anticholinergic medication such as scopolamine can be used. Prospective studies have demonstrated that a serotonin receptor antagonist may be effective when combined with midazolam. If a patient experiences persistent symptomatology, the balloon may be removed out of necessity.[26] Approximately 4 to 7% of patients have significant gastrointestinal symptoms after the first 7 days of therapy. Less than 3% of these patients require an endoscopic re-intervention or early balloon removal. The safety profile of intragastric balloons is of importance. Serious adverse events from the balloon, including gastric perforation, balloon migration, and mortality, are rare. A meta-analysis of intragastric balloon risks determined that gastric perforation rate is approximately 0.1%, balloon migration 1.4%, and mortality 0.08%.[27] Adverse events can be associated with the procedure or the balloon itself. Regarding balloon-related adverse events, serious events include gastric or esophageal perforation, gastric ulceration, and balloon migration can occur. These adverse events are primarily unique to the saline, liquid-filled balloons.[28] These include acute pancreatitis as well as spontaneous hyperinflation. The balloon migration or rupture risk is likely secondary to the balloon being in the stomach for an extended period than intended. If the balloon is left in the stomach longer than recommended, this poses a risk for rupture and migration into the small intestine. While most ruptures are excreted successfully, some may cause an intestinal obstruction. These patients should be closely monitored to ensure that the balloon is removed promptly to reduce the risk of migrations and intestinal obstruction.[29]

Adverse events can be associated with the procedure or the balloon itself. Regarding balloon-related adverse events, serious events include gastric or esophageal perforation, gastric ulceration, and balloon migration can occur. These adverse events are primarily unique to the saline, liquid-filled balloons.[28] These include acute pancreatitis as well as spontaneous hyperinflation. The balloon migration or rupture risk is likely secondary to the balloon being in the stomach for an extended period than intended. If the balloon is left in the stomach longer than recommended, this poses a risk for rupture and migration into the small intestine. While most ruptures are excreted successfully, some may cause an intestinal obstruction. These patients should be closely monitored to ensure that the balloon is removed promptly to reduce the risk of migrations and intestinal obstruction.[29] A safety precaution to detect rupture is dyeing the saline balloons with a blue dye. The patient may notice their urine turning blue or green as the ruptured dye is absorbed and then excreted renally. The dye serves as a warning mechanism so that the patient is aware of a rupture and can help retrieve it before the balloon migrates and causes a subsequent small bowel obstruction. Multi-balloon therapy can be advantageous for people over 1 with a single balloon. If 1 balloon ruptures, the second balloon may prevent the migration or subsequent obstruction.[30][31] Another adverse event of concern includes spontaneous hyperinflation. The FDA has received approximately 200 reports worldwide since 2015.[32] Greater than 99% of these cases involve the Orbera balloon therapy. Hyperinflation involves filling these balloons with an additional amount of either air or liquid once placed in the stomach, which typically necessitates early removal of the device. Another area of concern is that of acute pancreatitis. Acute pancreatitis can develop secondary to any intragastric balloon but has clinically been observed mainly with liquid-filled balloons. The FDA has received almost 30 adverse reports worldwide since 2015, with approximately 2/3 of these events involving the Orbera balloon system.[33]

A safety precaution to detect rupture is dyeing the saline balloons with a blue dye. The patient may notice their urine turning blue or green as the ruptured dye is absorbed and then excreted renally. The dye serves as a warning mechanism so that the patient is aware of a rupture and can help retrieve it before the balloon migrates and causes a subsequent small bowel obstruction. Multi-balloon therapy can be advantageous for people over 1 with a single balloon. If 1 balloon ruptures, the second balloon may prevent the migration or subsequent obstruction.[30][31] Another adverse event of concern includes spontaneous hyperinflation. The FDA has received approximately 200 reports worldwide since 2015.[32] Greater than 99% of these cases involve the Orbera balloon therapy. Hyperinflation involves filling these balloons with an additional amount of either air or liquid once placed in the stomach, which typically necessitates early removal of the device. Another area of concern is that of acute pancreatitis. Acute pancreatitis can develop secondary to any intragastric balloon but has clinically been observed mainly with liquid-filled balloons. The FDA has received almost 30 adverse reports worldwide since 2015, with approximately 2/3 of these events involving the Orbera balloon system.[33] The mechanism for acute pancreatitis can be secondary to either direct injury from the balloon or the distended stomach, which exerts pressure on the pancreatic parenchyma. Acute pancreatitis can also develop via an indirect mechanism where a pancreatic injury is secondary through a duodenal obstruction. Compression of the balloon onto the stomach may compromise blood flow to that region, leading to localized ischemia, ulceration, and eventual perforation. To diagnose this condition or recognize the clinical complications, a provider should look for the recent placement of a gastric balloon, the symptoms consistent with the diagnosis of pancreatitis, and biochemical or radiological evidence supporting pancreatitis. Laboratory work can consist of a lipase level, amylase, complete blood count, renal function test, and liver function tests. An abdominal CT or ultrasound can be used for radiological diagnosis.[20]

The mechanism for acute pancreatitis can be secondary to either direct injury from the balloon or the distended stomach, which exerts pressure on the pancreatic parenchyma. Acute pancreatitis can also develop via an indirect mechanism where a pancreatic injury is secondary through a duodenal obstruction. Compression of the balloon onto the stomach may compromise blood flow to that region, leading to localized ischemia, ulceration, and eventual perforation. To diagnose this condition or recognize the clinical complications, a provider should look for the recent placement of a gastric balloon, the symptoms consistent with the diagnosis of pancreatitis, and biochemical or radiological evidence supporting pancreatitis. Laboratory work can consist of a lipase level, amylase, complete blood count, renal function test, and liver function tests. An abdominal CT or ultrasound can be used for radiological diagnosis.[20] Adverse events can be secondary to the procedure, primarily during balloon removal. Adverse effects include gastrointestinal bleeding, esophageal tears, esophageal perforation, and pneumonia. Most balloons discussed require endoscopic retrieval and a needle to deflate the ballooning mechanism, sturdy grasper, or snare to remove the balloon. In terms of mortality, the FDA has received reports of 18 deaths worldwide from 2016 to the present in patients with a liquid-filled balloon system used to treat obesity.[34] Only 8 of these deaths involved patients in the US, 3 of which used the ReShape balloon and 5 with the Orbera balloon. Of these deaths, 1 occurred due to esophageal perforation, 2 from pulmonary embolism, 3 from gastric perforation, and the remaining 2 from unknown causes.[34] To accurately determine mortality, better studies are needed. These 18 deaths reported since 2016 are noted, but the incidence rate of death in those who underwent intragastric balloon therapy is unknown. A systematic review published in 2016 demonstrated a mortality rate of 0.05%.[35] More research is necessary for the incidence of death, but the FDA recommends that patients are both instructed and closely monitored for symptoms of life-threatening complications mentioned above. Balloon removal should be performed promptly if needed by a highly trained endoscopist.

The evaluation of the intragastric balloon and a multidisciplinary team approach was analyzed by a retrospective review of 119 balloons placed in 116 patients endoscopically from May 2001 to August 2006. In this review, 49 patients were followed by a multidisciplinary team every 15 days for 6 months, compared to 67 patients followed by individual providers. The patients followed by the multidisciplinary team had the most significant decrease in excess body weight and BMI. Conclusions from this analysis demonstrate that intragastric balloon therapy effectively achieves short-term weight loss in obese patients and that a multidisciplinary team approach combined with lifestyle augmentation markedly enhances weight loss. A multidisciplinary team is recommended before, during, and after intragastric balloon placement.[47]